Senior Regulatory Affairs Specialist

4 tygodni temu


Warszawa, Mazovia, Polska 9605 GSK Services Sp z o.o. Pełny etat

Senior Regulatory Specialist, CTA/IND

We are seeking a highly skilled Senior Regulatory Specialist to join our Polish Hub. This role will be responsible for coordinating, developing, and refining the CTA/IND lifecycle strategy, ensuring timely content delivery and compliance with GSK policy and procedures.

Key Responsibilities:

  • Develop and implement the CTA/IND lifecycle strategy, ensuring compliance with regulatory requirements and GSK policies.
  • Coordinate with cross-functional teams to ensure timely content delivery and submission to regulatory agencies.
  • Accountable for ensuring the quality of work and delivery of projects to agreed timeframes.
  • Provide input to internal processes and written standards.
  • Work flexibly to meet shifting priorities and timelines.

Requirements:

  • Min. Bachelor's degree in biological or healthcare science.
  • Relevant experience within Regulatory Affairs in the R&D, pharmaceutical industry or clinical trials.
  • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • Excellent organizational skills, attention to detail, and commitment to deliver high-quality output.
  • Ability to work in multiple IT systems and lead in a matrix environment.

What We Offer:

  • Contract of employment.
  • Hybrid work (2/3 days per week from the office).
  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit).
  • Life insurance and pension plan.
  • Private medical package with additional preventive healthcare services for employees and their eligible.
  • Sports cards (Multisport).
  • Possibilities of development within the role and company's structure.
  • Personalized learning approach (internal trainings, mentoring, access to online training' platforms).
  • Extensive support of work-life balance (flexible working solutions, short Fridays option, health & well-being activities).
  • Supportive community and integration events.


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